Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

NKB 2024-06-21

Invictus® Small Stature Spinal Fixation System

Applicant Alphatec Spine, Inc.

K-Number K241519

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LCX 2024-06-21

MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream

Applicant Guangzhou Decheng Biotechnology Co., Ltd.

K-Number K240643

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DQK 2024-06-21

Merge Hemo, Model RCSV2

Applicant Merge Healthcare Incorporated

K-Number K233326

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JWH 2024-06-20

ACTIFY 3D Total Knee System, ACTIFY Total Knee System

Applicant Globus Medical, Inc.

K-Number K240669

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MBI 2024-06-20

Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue

Applicant Smith & Nephew, Inc.

K-Number K241435

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ITI 2024-06-20

Electric wheelchair

Applicant Zhejiang Hfizer Medical Equipment Co., Ltd.

K-Number K240673

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GCJ 2024-06-20

SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)

Applicant Schoelly Fiberoptic GmbH

K-Number K233225

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SAN 2024-06-20

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System

Applicant Specific Diagnostics, LLC

K-Number K230675

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MAX 2024-06-20

Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System

Applicant SeaSpine Orthopedics Corporation

K-Number K241466

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GEX 2024-06-20

IVYLASER Diode laser hair removal system (IVY-HR-Alloy)

Applicant Ivylaser (Beijing) Technology Co.,Ltd

K-Number K240611

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EBW 2024-06-20

Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)

Applicant Nakanishi, Inc.

K-Number K233117

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MAX 2024-06-20

Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System

Applicant Orthofix Medical, Inc.

K-Number K240830

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